Recall Z-0392-05 ยท LHI Set, I.V. Fluid Transfer
Baxter Healthcare Corp.
Logix-CM Compounder Software, catalog 2M8400; Baxter Healthcare Corporation, Medication Delivery System, Round Lake, IL 60073
| Date | Dec 30, 2004 (initiated Dec 8, 2004) |
| Status | Terminated |
| Reason | A software anomaly in the Logix CM software could result in a drug mixture being compounded without one of the ingredients if two drugs have the same indentifier in Logix and another order entry program being used with the Logix software. |
| Root cause | Other |
| Action | Urgent Device Correction letters dated 12/8/04 were sent to the end users via overnight mail. The accounts were informed of the potential for omission of an ingredient if there are duplicate drug Id''s in the order, and were requested to complete and fax the customer reply form to Baxter at 847-270-5457, indicating if they are currently using Logix-CM software. Upon receipt of the reply form, Baxter will schedule a visit to the facility to examine the base and additive inventory information in their MOS database to confirm that there are no duplicate Drug ID numbers and that this issue has not |
| Quantity | 12 units |
| Distribution | Maryland, Arizona, Indiana, Ohio, Minnesota, Pennsylvania and internationally to Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.